Macugen Observational Study
26 de agosto de 2011 actualizado por: Pfizer
The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet age-related macular degeneration (AMD) in Indian patients.Prospective, Observational, Non-interventional Study.
The period of observation for the study will be 1 year
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD). The decision to prescribe Macugen will necessarily precede and will be independent of the decision to enroll patient into the study.
If both eyes of a patient receive injection Macugen, only one eye will be included in the study. If both eyes receive first injection Macugen after initiation of the study, only the first treated eye will be included in the analysis. If one eye has already received Macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis.
The study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on August 30, 2010. There were no safety concerns regarding the study in the decision to terminate the trial.
Tipo de estudio
De observación
Inscripción (Actual)
22
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Gujarat
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Navrangpura, Ahemdabad, Gujarat, India, 380009
- Pfizer Investigational Site
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Haryana
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Gurgaon, Haryana, India, 122 002
- Pfizer Investigational Site
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Kerala
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Cochin, Kerala, India, 682 015
- Pfizer Investigational Site
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Maharashtra
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Mumbai, Maharashtra, India, 400 054
- Pfizer Investigational Site
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Rajasthan
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Jaipur, Rajasthan, India, 302 004
- Pfizer Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).
Descripción
Inclusion Criteria:
- To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).
Exclusion Criteria:
- Active or suspected ocular or periocular infection.
- Known hypersensitivity to pegaptanib sodium or any other excipient in this product.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)
Periodo de tiempo: Baseline through 12 months or last follow-up visit before study termination
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VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light.
VA was assessed as the number of ETDRS letters correctly read.
VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.
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Baseline through 12 months or last follow-up visit before study termination
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Average Number of Injections to Achieve Stabilization of VA
Periodo de tiempo: 12 months or last follow-up visit before study termination
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Stabilization of VA was defined as loss of less than 15 letters in the BCVA.
For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted.
For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
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12 months or last follow-up visit before study termination
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Median Number of Injections to Achieve Stabilization of VA
Periodo de tiempo: 12 months or last follow-up visit before study termination
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Stabilization of VA was defined as loss of less than 15 letters in the BCVA.
Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method.
For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted.
For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
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12 months or last follow-up visit before study termination
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy
Periodo de tiempo: 12 months or last follow-up visit before study termination
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Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study.
Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study.
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12 months or last follow-up visit before study termination
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Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters
Periodo de tiempo: 12 months or last follow-up visit before study termination
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OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns.
The anatomic layers within the retina, retinal thickness could be measured.
Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).
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12 months or last follow-up visit before study termination
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Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters
Periodo de tiempo: 12 months or last follow-up visit before study termination
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A fluorescein angiogram provides information about the condition of the retina.
Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions.
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12 months or last follow-up visit before study termination
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Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA
Periodo de tiempo: 12 months or last follow-up visit before study termination
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Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA.
Stabilization of VA was defined as loss of less than 15 letters in the BCVA.
Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA.
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12 months or last follow-up visit before study termination
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Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions
Periodo de tiempo: 12 months or last follow-up visit before study termination
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Stabilization of VA was defined as loss of less than 15 letters in the BCVA.
For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted.
For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
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12 months or last follow-up visit before study termination
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Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions
Periodo de tiempo: 12 months or last follow-up visit before study termination
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Stabilization of VA was defined as loss of less than 15 letters in the BCVA.
Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method.
For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted.
For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
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12 months or last follow-up visit before study termination
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Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA
Periodo de tiempo: 12 months or last follow-up visit before study termination
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FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders.
VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA.
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12 months or last follow-up visit before study termination
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Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen
Periodo de tiempo: 12 months or last follow-up visit before study termination
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Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye.
Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen.
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12 months or last follow-up visit before study termination
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Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy
Periodo de tiempo: 12 months or last follow-up visit before study termination
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VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient's VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light.
VA was measured as the number of ETDRS letters correctly read.
VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA.
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12 months or last follow-up visit before study termination
|
|
Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy
Periodo de tiempo: 12 months or last follow-up visit before study termination
|
OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns.
The anatomic layers within the retina, retinal thickness could be measured.
Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).
Improvement in OCT parameters was measured based on this single parameter.
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12 months or last follow-up visit before study termination
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Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive
Periodo de tiempo: 12 months or last follow-up visit before study termination
|
OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns.
The anatomic layers within the retina, retinal thickness could be measured.
Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).
Improvement in OCT parameters was measured based on this single parameter.
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12 months or last follow-up visit before study termination
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2008
Finalización primaria (Actual)
1 de agosto de 2010
Finalización del estudio (Actual)
1 de agosto de 2010
Fechas de registro del estudio
Enviado por primera vez
14 de agosto de 2008
Primero enviado que cumplió con los criterios de control de calidad
14 de agosto de 2008
Publicado por primera vez (Estimar)
15 de agosto de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de agosto de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2011
Última verificación
1 de agosto de 2011
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A5751031
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .